Brief Title: Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Invasive Ductal Breast Carcinoma
• Invasive Ductal Breast Carcinoma Stage IV
• Lobular Breast Carcinoma
• Lobular Breast Carcinoma Stage IV
• Non Small Cell Lung Cancer
• NSCLC
• Gastrointestinal Cancer
• Gastrointestinal Squamous Cell Cancer
• Gastrointestinal Adenocarcinoma
• Pancreatic Cancer
• Bladder Cancer
• Renal Cell Carcinoma
• Melanoma
• Sarcoma
• Metastatic Solid Tumor

ELIGIBILITY

Inclusion Criteria:
* Patients with biopsy confirmed advanced/metastatic solid tumors of the following types: invasive ductal or lobular breast carcinoma (all histological and intrinsic subtypes), non-small cell lung cancer (NSCLC, all subtypes), gastrointestinal squamous cell or adenocarcinomas (including pancreatic cancer), bladder cancer, renal cell carcinoma, melanoma, and soft tissue sarcoma (all subtypes), who require and are being planned for palliative radiation therapy to at least one site of RECIST-measurable extracranial metastastic disease. If a patient, requires palliative radiotherapy to additional sites, these can be treated with standard of care SBRT per departmental guidelines.

- * Patients with at least one additional site of RECIST-measurable extracranial metastasis measuring at least 4 cm in one axis and suitable for elective palliative radiation therapy. Patients should be asymptomatic or minimally symptomatic (e.g controlled by oral pain medications) and not in urgent need for palliation to this site of elective experimental treatment.

- * Age ≥ 18 years

- * ECOG Performance Status of 0 or 1.
Exclusion Criteria:
* Patients who are pregnant or breastfeeding

- * Prior radiation therapy to the candidate metastatic sites under consideration for treatment ("re-irradiation" is disallowed).

- * Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.

- * Patients with a "currently active" metastatic second malignancy.

- * Patients on oral or parental corticosteroids. Physiological doses of steroids are permitted (eg for patients with adrenal insufficiency). If patients are on supraphysiological doses of steroids, these must be discontinued and held during the period of the study.

- * Concomitant anti-neoplastic treatment is not allowed during the days of radiation treatment delivery and should be completed or held for 3 days prior to commencement of protocol treatment and for 3 days following completion of radiotherapy, or with resolution of associated acute toxicities.

- * Unwilling or unable to participate in all required study evaluations and procedures.

- * Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Atif Khan, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Atif Khan, MD, Christopher Barker, MD

Phone: 848-225-6334, 212-639-8168

Email: khana7@mskcc.org, barkerc@mskcc.org

LOCATION